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510(k) K801891

WAKO TRIGLYCERIDE-G TEST by Wako Pure Chemical Industries, Ltd. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Wako Pure Chemical Industries, Ltd.

  • K842221 — WAKO GLUCOSE C (July 12, 1984)
  • K813366 — AMMONIA TEST (December 22, 1981)
  • K801834 — WAKO HDL CHOLESTEROL TEST (September 16, 1980)
  • K801076 — WAKO PHOSPHOLIPIDS TEST (June 30, 1980)
  • K791597 — WAKO TRIGLYCERIDE (September 17, 1979)

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